Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211165
Company: MACLEODS PHARMACEUTICALS LTD
Company: MACLEODS PHARMACEUTICALS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VORTIOXETINE HYDROBROMIDE | VORTIOXETINE | 20MG | TABLET:FILM COATED | None (Tentative Approval) | None | No | No |
| VORTIOXETINE HYDROBROMIDE | VORTIOXETINE | 10MG | TABLET:FILM COATED | None (Tentative Approval) | None | No | No |
| VORTIOXETINE HYDROBROMIDE | VORTIOXETINE | 15MG | TABLET:FILM COATED | None (Tentative Approval) | None | No | No |
| VORTIOXETINE HYDROBROMIDE | VORTIOXETINE | 5MG | TABLET:FILM COATED | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/10/2025 | ORIG-1 | Tentative Approval | STANDARD |
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